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NCT Number: NCT06242405

Effect of Different Frequencies of Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With ESLD

Stem cells are non-terminal cells that can self renew and replicate through symmetric or asymmetric division, with the potential to differentiate into different types of cells and tissues. Multiple studies have shown that mesenchymal stem cell has good safety and effectiveness in improving acute or chronic liver injury. Randomized controlled trials have confirmed the efficacy of single infusion of stem cells in treating ESLD. It seems that the multiple infusion is better than single infusion.

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Key information

Conditions

End-Stage Liver DIsease Digestive System Diseases End Stage Liver Disease Fibrosis Hepatic Insufficiency Liver Diseases Liver Failure Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

General Hospital of Northern Theater Command

Shenyang, Liaoning, 110840, China

About this study

Ninety-two participants with end-stage liver disease admitted to the Department of Gastroenterology of the General Hospital of Northern Theater Command are expected to be enrolled over a period of 1 year. The participants will be randomly divided into single-infusion and double-infusion stem cell groups by peripheral vein. The investigators will observe alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, albumin, prothrombin time, international normalized ratio, model for end-stage liver disease score, and Child-Pugh score in patients at weeks 24 post-infusion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 18-80 years old
  • 2. End-stage liver disease
  • 3. Signed informed consent

Exclusion criteria

  • 1. Tumours of the liver or other organs
  • 2. Liver transplantation recipients
  • 3. Acute myocardial infarction, acute heart failure, type I and type II respiratory failure, pulmonary embolism, acute cerebral infarction, acute cerebral haemorrhage and other serious cardiopulmonary diseases
  • 4. Other diseases that may seriously affect the survival
  • 5. Human immunodeficiency syndrome
  • 6. Interferon or glucocorticoid therapy within 1 year
  • 7. Treated for mental illness
  • 8. Participation in other clinical trials within 30 days
  • 9. Pregnant or breastfeeding subjects
  • 10. Allergic asthma, allergic urticaria, eczema, or a history of multiple drug and food allergies
  • 11. Other circumstances that are unsuitable for participation in this study

Treatment and study plan

umbilical cord-mesenchymal stem cells

Biological

Umbilical cord mesenchymal stem cells injected through peripheral veins

Other names: UC-MSCs

Primary outcomes

  1. Proportion of patients with Child A

    Time frame: 24 weeks

    Patients with Child A

Secondary outcomes

  1. Change in liver function parameters

    Time frame: 24 weeks

    Values of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, serum albumin, prothrombin time, and international normalized ratio and the scores of MELD and Child-Pugh

  2. Incidence of hepatic decompensation events

    Time frame: 24 weeks

    Number of patients who will develop gastrointestinal bleeding, ascites and hepatic encephalopathy

  3. Survival rate and liver transplant rate

    Time frame: 24 weeks

    Number of patients surviving and undergoing liver transplantation

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

Efficacy and Safety of Different Frequencies of Human Umbilical Cord-mesenchymal Stem Cells Through Peripheral Vein in Patients With End-stage Liver Disease

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 5, 2024
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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